NC0006564_Temperature Study_20230526

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ROY COOPERr
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Govenor , ' � '
ELIZABETH S.BISER %
Secretary �Vuwv .-
RICHARD E.ROGERS,JR. NORTH CAROLINA
Director Environmental Quality
May 26,2023
Mr. Brian Smith,EHS Director
Baxter Healthcare Corporation
65 Pitts Station Road
Marion,North Carolina 28752
Subject: Temperature Study
Permit NC0006564
Baxter Healthcare Corp.WWTP
McDowell County
Dear Mr. Smith,
The Division of Water Resources (DWR) NPDES Industrial Permitting Unit (IPU) appreciates meeting
with the Baxter Team and discussing concerns related to temperature limits and the Temperature
Compliance Schedule (TCS) as specified in the NPDES Permit renewed on 11/01/2022. Excerpts of the
TCS and Pertinent Considerations / Facts are included herein as Attachments 1 and 2 for ease of reference
and historical reference.
DISCUSSION ITEMS
During the meeting the following were discussed:
1. A potential variances for temperature,
2. A potential reassessment of existing classification of the discharge waters (North Fork Catawba River)
as B-Trout Waters (Tr),
3. Additional time to complete the Corrective Action Plan as specified in condition 1 of Section A. (3.)
Schedule of Compliance Temperature Outfall 001 and Instream [G.S. 143-215.1(b)] of the NPDES
Permit renewed on 11/01/2022. Details of that required Plan and additional actions related to
temperature are included herein as Attachment 1 for ease of reference,
4. New sanitation practices at the Baxter facility.
D E Q North Carolina Department of Environmental Quality I Division of Water Resources
512 North Salisbu y Street 11611 Mail Service Center I Raleigh,North Carolina 27699-1611
e .a�o.ra\ /*/
919.707.9000

DWR RESPONSES
In general, DWR understands that sanitation, sterilization and maintaining a sterile work environment are
critical to the pharmaceutical industry. We also understand and appreciate the complexity of the regulatory
arena that affects all industries, specifically FDA regulations which have prompted the considerations
proposed by the Baxter Team.
Specific responses are numbered below for ease of reference.
1. Official Submittal: Any requests should be officially submitted to DWR for consideration along
with a revised / updated copy of the May 1, 2023 "Temperature Study Submittal".
2. Temperature Variance: As discussed during the meeting variances are difficult to secure and
require EPA approval.If the goal is to seek a temperature variances,please submit an official request.
Be cognizant of the fact that variance request include a significant public process.
3. Re-assessing Water Classification(s). As discussed during the meeting, changing existing water
classifications is a lengthy and difficult process.If the goal is to request a classification change,please
submit an official request.Be cognizant of the fact that such request/change(s) include a significant
public process.
4. Additional Time: If you wish to request an extension of the September 1,2023 deadline to submit
the Corrective Action Plan specified in Condition A. (3.) of the NDPES permit, please submit an
official request with a complete explanation of the reasons why an extension of time is necessary.
This additional time may be provided via a minor permit modification (per 40 CFR Part 122.63),
provided the new date(s) are not more than 120 days after the interim compliance date(s) specified
in the existing permit and it does not interfere with attainment of the final compliance date (March
1,2026). Otherwise, this request (if justified),would require a major NPDES permit modification.
5. All Contributing Flows: Evaluate and include in revised/updated report(including a revised/updated
Table 2-1) each flow from the facility with any thermal contribution to influent (not only major ones)
such as boiler blowdown, DW Auxiliary, sterilization, extrusion, cooling tower blowdown,
overflows,etcetera. Include in this evaluation at a minimum the: flow,temperature, and destination
(e.g., Cooling Recirculation or iVI for each flow with a thermal contribution. For the overflow from
the cooling ponds that is sent to the WWTP, this evaluation should also include an explanation of
the circumstances under which overflow is sent to the WWTP, the frequency of overflow, the
volume/flow of overflow, the temperature of overflow, and the impact of overflow on the effluent
temperature. Appendices A and B of the submitted study should be revised as necessary.
6. Data Richness and Diurnal Monitoring: Data richness plays an essential role in compliance
determination and next steps. Please provide diurnal monitoring results (hourly or more frequent) for
the effluent in comparison with ambient air temperature, and heat exchange capacity.
7. New Monitoring Data and spreadsheet Format: Provide the new monitoring data from this
study (excluding eDMR) in an original spreadsheet format for further examination.
8. Fish Community Study: Provide fish community study results.
North Carolina Department of vironmental Quality I Division of Water Resources
512 North Salisbury Street 116lEn 1 Mail Service Center I Raleigh,North Carolina 27699-1611
.a "" _� 919.707.9000

9. Details on New Operations: Provide evaluation for adopting new operation plans due to FDA
requirements in comparison to current operation status in regards thermal contribution to effluent.
If such evaluation is not feasible currently,please provide a timeline on when it would be available.
10. Other Details Discussed During Meeting: Provide requested details not captured in above items
but mentioned in the meeting by DWR staff or AG office.
DWR appreciates Baxter's proactiveness in this matter. Please address the mentioned items and resend a
revised copy at your first convenience,but no later than thirty(30) days from the date of this letter.We look
forward to working with you.
If you have any questions please contact Amir Adaryani, PhD at: amir.adaryania,deq.nc.gov or Doug
Dowden at: doug.dowdenadeq.nc.gov.
Respectfully,
DocuSigned by:
Qw1iV{1.4SSUt& I4,A6 4daYtiou-
`-6258FEA6822C486...
Amirhossein (Amir) Rezaei Adaryani, PhD
Environmental Engineer,DWR IPU
cc: Central Files;NPDES Files
ec: Jaime Robinson Senior Project Manager Jacobs at: jaime.robinson(a,jacobs.com,
Brian Smith Quality Manager at Baxter International Inc at: brian d [e-mail],
Lisa Zak Associate General Counsel Baxter International at: lisa [e-mail],
Sean M. Sullivan Environmental Attorney Robinson Bradshaw at: [e-mail],
Cortney Cameron Professional Geologist&Professional Wetland Scientist Jacobs at:
cortney.cameron( jacobs.com,
Kristin Vaughn-Morico,PE,Vice President, Environment, Health Safety and Sustainability Baxter
International at Kristin [e-mail],
Francisco Benzoni, Special Deputy Attorney General at NC Dept. of Justice at: fbenzoni(a,ncdoj.gov;
Doug Dowden, Environmental Program Supervisor at: doug.dowden(a,deq.nc.gov,
Sergei Chernikov,PhD Environmental Engineer III DWR at sergei.chernikovna,deq.nc.gov,
Michael Montebello,Section Chief DWRC at Michael.montebello(a,deq.nc.gov,
Julie Grzyb,Deputy Director DWR at:[e-mail],
Daniel Boss,Assistant Supervisor Asheville Regional office at: Daniel.bossadeq.nc.gov,
Landon Davidson Regional Office Supervisor Asheville Regional Office landon.davidson( deq.nc.gov,
North Carolina Department of Environmental Quality I Division of Water Resources
p MW �� 512 North Salisbury Street 11611 Mail Service Center I Raleigh,North Carolina 27699-1611
919.707.9000

DocuSign Envelope ID:48F96D1D-97D2-4DEB-AF5D-5C92ED59E9E2
Baxter Healthcare Corp NC0006564
Part I
A. (1.) EFFLUENT LIMITATIONS AND MONITORING REQUIREMENTS
[15A NCAC 02B .0400 et seq., 02B .0400 et seq.]
[15A NCAC 02B .0400 et seq., 02B .0500 et seq.]
[15A NCAC 08G .0302] Grade III Biological Water Pollution Control System
During the period beginning on the effective date of the permit and lasting until expiration, the Permittee is
authorized to discharge treated non-contact cooling water,boiler feed water,process wastewater, and
sanitary wastewater from outfall 001. Such discharges shall be limited and monitored9 by the Permittee as
specified below:
PARAMETER EFFLUENT LIMITATIONS MONITORING REQUIREMENTS
Parameter Code Monthly Average Daily Maximum Measurement Sample Sample
Frequency Type Locations
Flow 50050 1.2 MGD Continuous Recording I or E
BOD5(20°C)2 QD310 460.9 pounds/day 691.4 pounds/day Weekly Composite I and E
CODS 00340 1,292.8 pounds/day 1,939.2 pounds/day Weekly Composite I and E
Total Suspended Solids QD530 278.0 pounds/day 417.0 pounds/day Weekly Composite E
Ammonia (NH3 as N)(conc) C0610 5.3 mg/L 26.4 mg/L Once/2 Months Composite E
(April 1 -October 31)
Ammonia (NH3 as N) (conc) C0610 14.7 mg/L Once/2 Months Composite E
1 (November 1—March 31)
Fecal Coliform 31616 200/100 mL 400/100 mL E
(geometric mean) Weekly Grab
Total Residual Chlorine4 50060 28 pg/L 3/Week Grab E
Dissolved Oxygen 00300 Monitor and Report 3/Week Grab E
Temperature, °C8 00010 Monitor and Report 3/Week Grab E
Conductivity 00094 Monitor and Report 3/Week Grab E
Turbidity, NTU10 10 Weekly Grab E
Oil and Grease 00556 47.7 pounds/day 95.4 pounds/day 2/Month Grab E
pH 00400 Between 6.0 and 9.0 standard units 3/Week Grab E
Temperature, °C7'8 00010 Monitor and Report 3/Week Grab U and D
Total Nitrogen, mg/L C0600 Monitor and Report Monthly Composite E
Total Phosphorus, mg/L C0665 Monitor and Report Monthly Composite E
Fecal Coliform' 31616 Monitor and Report 3/Week Grab U and D
(geometric mean)
Conductivity' 00094 Monitor and Report 3/Week Grab U and D
Dissolved Oxygen' 00300 Monitor and Report 3/Week Grab U and D
Total Hardness
[as CaCO3 mg/L] 00900 Monitor and Report Quarterly Composite E
Total Hardness 00900 Monitor and Report
[as CaCO3 mg/L6] P Quarterly Grab U
Chronic Toxicitys TGP3B See Note 5
Quarterly Composite E
Footnotes:
1. Sample Locations: E—Effluent. U-Upstream: at least 100 feet upstream from the outfall.D -Downstream at
NCSR 1552.
2. The monthly average effluent BOD5 concentration shall not exceed the respective influent value multiplied by 0.3
per 40 CFR 439.12(a).
3. The monthly average effluent COD concentration shall not exceed the respective influent value multiplied by 0.572
per 40 CFR 439.12(d).
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ATTACHMENT 2
Pertinent Considerations / Facts
The Per 15A NCAC 02B .0211 (18) and (21), the temperature for trout waters shall not be increased by
more than 0.5 degrees Celsius, due to the discharge of heated liquids; and not to exceed 20 degrees Celsius;
and turbidity in streams designated as trout waters shall not exceed 10 NTUs. Instream and effluent
monitoring can be added to the permit.
The DWR Water Planning section notes that the segment below the discharge on the North Fork Catawba
River is impaired for aquatic life for benthic macroinvertebrates, which is likely due from both point and
nonpoint sources of pollution. The current Catawba River Basin Plan was implemented in 2018, and the
plan is currently scheduled to being reviewed in 2023. However, ambient water quality samples are
collected monthly and quarterly across the state, for assurance that state water quality standards are met
based on the waterbody's classification. The Water Sciences Section, Intensive Survey Branch, which
conducts the Ambient Lake Monitoring program, confirmed that when the western part of Lake James
was assessed during the summer in 2012 and 2015, potentially harmful algae/cyanobacteria increased in
June and were dominate from July to September. The Lakes Assessment program will or has monitored
Lake James in the 2022/2023 period with attention on phytoplankton species.
QA North Carolina Department of Environmental Quality I Division of Water Resources
D E
, ), 512 North Salisbury Street 1161 1 Mail Service Center I Raleigh,North Carolina 27699-1611
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DocuSign Envelope ID:48F96D1D-97D2-4DEB-AF5D-5C92ED59E9E2
Baxter Healthcare Corp NC0006564
A. (2.) CHRONIC TOXICITY PERMIT LIMIT (Quarterly)
[15A NCAC 02B .0200 et seq.]
The effluent discharge shall at no time exhibit observable inhibition of reproduction or significant mortality
to Ceriodaphnia dubia at an effluent concentration of 16.0%.
The permit holder shall perform at a minimum, quarterly monitoring using test procedures outlined in the
"North Carolina Ceriodaphnia Chronic Effluent Bioassay Procedure,"Revised December 2010,or subsequent
versions or"North Carolina Phase II Chronic Whole Effluent Toxicity Test Procedure" (Revised-December
2010) or subsequent versions.The tests will be performed during the months of February,May,August,
and November.These months signify the first month of each three-month toxicity testing quarter assigned
to the facility. Effluent sampling for this testing must be obtained during representative effluent discharge and
shall be performed at the NPDES permitted final effluent discharge below all treatment processes.
If the test procedure performed as the first test of any single quarter results in a failure or ChV below
the permit limit,then multiple-concentration testing shall be performed at a minimum,in each of
the two following months as described in"North Carolina Phase II Chronic Whole Effluent Toxicity
Test Procedure" (Revised-December 2010) or subsequent versions.
All toxicity testing results required as part of this permit condition will be entered on the Effluent Discharge
Monitoring Form (MR-1) for the months in which tests were performed,using the parameter code TGP3B
for the pass/fail results and THP3B for the Chronic Value.Additionally,DWR Form AT-3 (original)is to be
sent to the following address:
Attention: North Carolina Division of Water Resources
Water Sciences Section/Aquatic Toxicology Branch
1621 Mail Service Center
Raleigh,North Carolina 27699-1621
Or,results can be sent to the email,ATForms.ATB@ncdenr.
gov.
Completed Aquatic Toxicity Test Forms shall be filed with the Water Sciences Section no later than 30 days
after the end of the reporting period for which the report is made.
Test data shall be complete,accurate,include all supporting chemical/physical measurements and all
concentration/response data,and be certified by laboratory supervisor and ORC or approved designate
signature.Total residual chlorine of the effluent toxicity sample must be measured and reported if chlorine is
employed for disinfection of the waste stream.
Should there be no discharge of flow from the facility during a month in which toxicity monitoring is
required,the permittee will complete the information located at the top of the aquatic toxicity(AT) test form
indicating the facility name,permit number,pipe number,county,and the month/year of the report with the
notation of"No Flow"in the comment area of the form. The report shall be submitted to the Water Sciences
Section at the address cited above.
Should the Permittee fail to monitor during a month in which toxicity monitoring is required,monitoring will
be required during the following month.Assessment of toxicity compliance is based on the toxicity testing
quarter,which is the three-month time interval that begins on the first day of the month in which toxicity
testing is required by this permit and continues until the final day of the third month.
Should any test data from this monitoring requirement or tests performed by the North Carolina Division of
Water Resources indicate potential impacts to the receiving stream,this permit may be re-opened and
modified to include alternate monitoring requirements or limits.
NOTE: Failure to achieve test conditions as specified in the cited document,such as minimum control
organism survival,minimum control organism reproduction,and appropriate environmental controls,shall
constitute an invalid test and will require immediate follow-up testing to be completed no later than the last
day of the month following the month of the initial monitoring.
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DocuSign Envelope ID:48F96D1D-97D2-4DEB-AF5D-5C92ED59E9E2
Baxter Healthcare Corp NC0006564
4. Chlorine limit and monitoring requirements apply only if chlorine is used.The facility shall report all effluent TRC
values reported by a NC certified laboratory including field certified.However,effluent values below 50 µg/L will be
treated as zero for compliance purposes.
5. Chronic Toxicity(Ceriodaphnia)at 16%:Feb,May,Aug,Nov(see A. (2.)).
6. The Permittee shall sample instream hardness,upstream of the facility's discharge.The sample shall be
representative of the hardness in the receiving stream.If the Permittee is a member of the Monitoring Coalition
Program,sampling for instream hardness may be waived as long as the Monitoring Coalition agrees to sample
hardness at the nearest upstream location,at a minimum frequency of quarterly,and the Permittee has obtained
approval from DWR-NPDES Permitting Unit that the upstream station being monitored by the Coalition is
representative of the receiving stream for this discharge.The Permittee is responsible for submitting instream
hardness test results with its permit renewal application package.If Coalition membership is cancelled or the
Coalition terminates instream hardness sampling at the approved station,the Permittee will immediately notify the
Division and resume sampling for instream hardness,upstream of its discharge.
7. Sample collected three times per week during June 1 through September 30 and once per week October 1 through
May 31.
8. By March 1,2026,the facility shall not exceed the instream water temperature of 20°C and not exceed 0.5°C above
the background temperature.If the instream temperature exceeds 20°C upstream of the facility,the discharge will
not be considered out of compliance with this permit limit based on the maximum regulatory limit of 20°C
provided that it does not increase the background temperature. Please see Special Condition A.(3.) for compliance
schedule.
9. Starting on December 21,2016,begin submitting Discharge Monitoring Reports electronically using NC DWR's
eDMR application system.Please See Special Condition A. (5.).
10. Please see condition A. (4.).
There shall be no discharge of floating solids or visible foam in other than trace amounts.
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DocuSign Envelope ID:48F96D1D-97D2-4DEB-AF5D-5C92ED59E9E2
Baxter Healthcare Corp NC0006564
A. (3.) SCHEDULE OF COMPLIANCE TEMPERATURE OUTFALL 001 AND
INSTREAM [G.S. 143-215.1(b)]
1. Effective no later than May 1,2023,the Permittee shall submit to the Division of Water Resources a
temperature study analyzing the impacts of each wastestream on the facility's effluent temperature
under diverse operating and ambient conditions,and characterizing the impacts of the facility's
effluent on receiving stream temperature under diverse operating and ambient conditions.
2. Within four months of completion of the temperature study and no later than September 1,2023,
the Permittee shall submit to the Division,a Corrective Action Plan(CAP) for approval that
summarizes the actions to be taken to achieve compliance with 15A NCAC 02B 0211(18) and.0219.
The time to compliance shall be no longer than two years and six months from the date of
submission of the CAP.The CAP shall include,at a minimum,a summary of the options analyzed,a
detailed analysis of the Permittee's preferred alternative,including preliminary design engineering and
a schedule for procurement of funds and/or approvals,construction,and necessary operation
changes.The CAP shall propose a schedule for completion of critical milestones until compliance is
achieved.The Division will provide comments and direction,if deemed necessary,within ninety(90)
days of CAP submittal.If no such direction is provided,the CAP shall be considered approved.
3. Effective no later than September 1,2024,the Permittee shall submit a progress report to the
Division summarizing the actions taken in accordance with CAP and schedule,including
procurements,construction,installation,or other measures.
4. Effective no later than September 1,2025,the Permittee shall submit a progress report to the
Division summarizing the actions taken in accordance with CAP and schedule,including
procurements,construction,installation,or other measures.
5. Effective no later than March 1,2026,the Permittee shall achieve compliance with temperature
limits specified in condition A. (1.)
In addition to steps 1 through 5,upon approval of the CAP by the Division,the milestones outlined in the
CAP become an enforceable part of the permit.Any modification to the schedule for these milestones must
be requested to the Division at least ninety(90) days before scheduled deadline.Modifications more than four
(4) months or more than one 4-month modification request to the schedule will be subject to public notice.
The CAP and reports shall include the owner's name,NPDES permit number and Permittee contact person,
and shall be submitted to:
(1) NC Division of Water Resources (2)NCDEQ,Division of Water Resources
NPDES industrial permitting unit Asheville Regional Office
1617 Mail Service Center 2090 U.S. 70 Highway
Raleigh,NC 27699-1617 Swannanoa,NC 28778
Force Majeure:Any noncompliance with the schedule specified in condition A. (3.) shall not be considered a
permit violation if the Permittee satisfies DEQ that noncompliance was caused solely by:
a. An act of God;
b. An act of war;
c. An intentional act or omission of a third party,but this defense shall not be available if the act or
omission is that of an employee or agent of Baxter or if the act or omission occurs in connection with a
contractual relationship with Baxter;
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DocuSign Envelope ID:48F96D1D-97D2-4DEB-AF5D-5C92ED59E9E2
Baxter Healthcare Corp NC0006564
d. An extraordinary event beyond the Baxter's control, specifically including any court order staying the
effectiveness of any necessary permit or approval. Contractor delays or failure to obtain funding will not be
considered as events beyond Baxter's control;or
e. Any combination of the above causes.
A. (4.) TURBIDITY MONITORING [G.S. 143-215.1(b)]
Permittee can apply for a major modification after providing 12 months of turbidity monitoring data,
requesting for reduction of turbidity monitoring frequency or its elimination.The request may be approved if
the facility demonstrates a consistent turbidity measurement below 10 NTU in its effluent.
A. (5.) ELECTRONIC REPORTING OF DISCHARGE MONITORING REPORTS
[G.S. 143-215.1(b)]
Federal regulations require electronic submittal of all discharge monitoring reports (DMRs) and program
reports and specify that,if a state does not establish a system to receive such submittals,then permittees must
submit monitoring data and reports electronically to the Environmental Protection Agency(EPA).The final
NPDES Electronic Reporting Rule was adopted and became effective on December 21,2015.
NOTE:This special condition supplements or supersedes the following sections within Part II of this permit
(Standard Conditions for NPDES Permits):
• Section B. (11.) Signatory Requirements
• Section D. (2.) Reporting
• Section D. (6.) Records Retention
• Section E. (5.) Monitoring Reports
1. Reporting Requirements [Supersedes Section D. (2.) and Section E. (5.) (a)]
Effective December 21,2016,the permittee shall report discharge monitoring data electronically using
the NC DWR's Electronic Discharge Monitoring Report(eDMR) internet application.
Monitoring results obtained during the previous month(s) shall be summarized for each month and
submitted electronically using eDMR.The eDMR system allows permitted facilities to enter monitoring
data and submit DMRs electronically using the internet. Until such time that the state's eDMR
application is compliant with EPA's Cross-Media Electronic Reporting Regulation (CROMERR),
permittees will be required to submit all discharge monitoring data to the state electronically using eDMR
and will be required to complete the eDMR submission by printing, signing,and submitting one signed
original and a copy of the computer printed eDMR to the following address:
NC DENR/Division of Water Resources /Water Quality Permitting Section
ATTENTION: Central Files
1617 Mail Service Center
Raleigh,North Carolina 27699-1617
If a Permittee is unable to use the eDMR system due to a demonstrated hardship or due to the facility being
physically located in an area where less than 10 percent of the households have broadband access,then a
temporary waiver from the NPDES electronic reporting requirements may be granted and discharge
monitoring data may be submitted on paper DMR forms (MR 1, 1.1,2,3) or alternative forms approved by
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